Informations générales (source: ClinicalTrials.gov)
Treatment of Opioid-refractory Pain (WHO Level III) by Pituitary Radiosurgery: A Multicenter, Prospective, Randomized Study (Hyporadoul)
Interventional
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
décembre 2015
décembre 2025
05 avril 2025
80% of palliative care cancer patients suffer from severe pain. The management of these
pain improves the quality of life of these patients. The management of opioid pain
refractory to date remains a difficulty for caregivers. Hypophysectomy performed to try
to control hormone-dependent neoplasia also help relieve pain associated with lesions
secondary cancer. The surgical hypophysialis radio Gamma Knife ® was recently performed
on a small number of patients. She would have the advantage of reducing the risk of
complications compared to other techniques and achieve similar analgesic effect on
diffuse, or mixed nociceptive pain associated with metastases on average in 2 days and
would reduce or stop opiates most often responsible for side effects impairing the
quality of life. The objective of this clinical trial, multicenter, prospective,
randomized controlled is to evaluate the effectiveness of surgical hypophysialis radio
for patients in palliative situations with refractory cancer pain in opioid level III.
The type of pain "cancer pain" was done in order to optimize the recruitment and
homogenization of the study population: patients cared for in palliative care units are
mostly patients cancer (70-80%). This study is therefore part of a palliative setting and
the results of this test can be extrapolated to other populations of palliative patients
with refractory pain.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Marseille - 13354 - Marseille - France | DESALBRES Urielle, Director | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Man or woman, aged 18 years or older;
- Subject suffering from nociceptive or mixed pain, not related to acts, refractory to
standard opioid therapy
- Subject having a cancer defined by histology whatever the origin of the primitive
cancer,
- Subject having multiple bone metastases
- Subject in palliative care state according to the definition given by the French
Society of Palliative Care and Support
- Subject supported by structures of palliative care, pain or cancer involved in the
study
- Inpatient and outpatient
- Subject without a curative cancer treatment and with or without palliative
anticancer treatment;
- Subject non in "ultimate" phase (estimated survival superior at 48 h by a physician)
- Subject with acceptable general condition (Karnofsky performance Status Scale
superior at 40
- Subject with a preserved vigilance defined from the Epworth scale
- Subject with preserved cognition according to the scale Basic Test Concentration,
Memory and Guidance (TELECOM)
- Subject which can fill in a questionnaire, able to read or to understand the French
language;
- Subject who signed an informed consent;
- Subject affiliated to the French health insurance system.
- Man or woman, aged 18 years or older;
- Subject suffering from nociceptive or mixed pain, not related to acts, refractory to
standard opioid therapy
- Subject having a cancer defined by histology whatever the origin of the primitive
cancer,
- Subject having multiple bone metastases
- Subject in palliative care state according to the definition given by the French
Society of Palliative Care and Support
- Subject supported by structures of palliative care, pain or cancer involved in the
study
- Inpatient and outpatient
- Subject without a curative cancer treatment and with or without palliative
anticancer treatment;
- Subject non in "ultimate" phase (estimated survival superior at 48 h by a physician)
- Subject with acceptable general condition (Karnofsky performance Status Scale
superior at 40
- Subject with a preserved vigilance defined from the Epworth scale
- Subject with preserved cognition according to the scale Basic Test Concentration,
Memory and Guidance (TELECOM)
- Subject which can fill in a questionnaire, able to read or to understand the French
language;
- Subject who signed an informed consent;
- Subject affiliated to the French health insurance system.
- Subject with a curative cancer treatment
- Subject in "ultimate" phase (estimated by the physician of survival less than 48
hours)
- History of whole brain radiation
- History of radiosurgery of pituitary lodge
- Subject treated there less than a month by external or metabolic radiotherapy
analgesic, surgical analgesic technic
- Subject minor, pregnant or breastfeeding, subject not being affiliated to the French
health insurance system or private about freedom;
- Subject refusing to participate in the study or not signing the informed consent.
- Subject allergic to any component of Fludeoxyglucose (18F)
- Subject allergic to gadolinium salts.
- Subject with severe renal impairment